Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine · 1 trial · 1 indication
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
| Arm | Type | Description |
|---|---|---|
| GSK 257049-Lot 1 Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Lot 2 Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Lot 3 Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Pilot Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) | BIOLOGICAL | 4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination. * Sig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
It is an investigational vaccine developed by GSK plc (ticker GSK) against Plasmodium falciparum malaria. It is a Phase 3 candidate studied in children, and it is also identified in trial records by the code 257049. It is not an approved product and remains in clinical development.
It is being developed for the prevention of malaria caused by Plasmodium falciparum. The clinical program has studied the vaccine in children, with the youngest participants enrolled from 5 months of age. The vaccine is investigational and has not been established as an approved preventive option.
The vaccine is developed by GSK plc, which trades under the ticker GSK. It is referred to as a GSK Biologicals' candidate, reflecting the company's vaccines organization. GSK is the sponsor of the clinical program evaluating the candidate in children.
It is in Phase 3 development. One Phase 3 trial has been completed, and no trials of this candidate are currently listed as active. The vaccine is investigational and is not described as approved for any indication.
The candidate has been evaluated in trial NCT01323972, titled Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children. That Phase 3 trial was completed, enrolled 327 participants, was randomized, double blind, and controlled, and was conducted in Nigeria.
Yes. GSK Biologicals' candidate Plasmodium falciparum malaria vaccine is also known as GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049). The number 257049 is an alternate identifier used for the same investigational malaria vaccine candidate developed by GSK plc.